Device Recalls Blamed on Lax FDA Approval Path

Action Points

Explain that a large proportion of the medical devices recalled in recent years because they posed a significant safety hazard made their way to market via the FDA's less stringent 510(k) approval program.

Note that cardiovascular devices comprised the largest recall category, accounting for 31% of high-risk recalls, whereas the next largest risk category (24% of recalls) involved general hospital devices.

A large proportion of the medical devices recalled in recent years because they posed a significant safety hazard made their way to market via the FDA's less stringent 510(k) approval program, researchers say.

In a review of 113 urgent recalls from 2005 to 2009, more than 70% of the recalled devices were found to have been cleared via the 510(k) program -- compared with 19% approved through the FDA's more rigorous premarket approval (PMA) system, Steven Nissen, MD, of the Cleveland Clinic, and colleagues reported.

The findings demonstrate "systematic problems" in current medical device regulation "that have exposed patients to serious harm," Nissen and co-authors wrote in the Feb. 14 issue of the Archives of Internal Medicine.

"There should be NO recalls for 'serious injuries or death' amongst 510(k) approved devices," Nissen said in an e-mail to MedPage Today. "The FDA is supposed to require a PMA for Class III devices, those used to sustain life or preserve health.

"If a PMA is required for devices used to support or sustain life," Nissen continued, "why were so many of the devices recalled for 'serious injury or death' originally approved using 510(k)?"

Several researchers contacted by MedPage Today and ABC News via e-mail said the study highlights a major flaw in the FDA approval process for medical devices.

"The system is set up so that safety and innovation are opposed to each other. It doesn't have to be that way," said Cam Patterson, MD, of the University of North Carolina at Chapel Hill. "The requirements for premarket testing have gotten so over the top that it is almost considered the kiss of death for a company if the FDA requires their product to reach approval through this pathway."

"This creates a perverse incentive for companies to seek 510(k) approval rather than premarket testing," Patterson added. "This situation may reflect in part the observations in this study."

Mark Adelman, MD, of the NYU Langone Medical Center in New York City, called the 510(k) program a "double-edged sword."

"While some lives have been lost by expedited approval, many lives have been saved by getting better devices to market quickly," Adelman said. "How many lives have been saved by the 510(k) fast track?

Several other physicians contacted by MedPage Today and ABC News via e-mail noted the need for a balance between expensive premarket testing and getting devices to market fast enough to save lives.

They also pointed out that Nissen and colleagues didn't compare the proportions of devices recalled in each category.

Nissen acknowledged in his e-mail to MedPage Today that a "higher percentage of PMAs result in serious injuries or deaths, but we think that is not very relevant." Rather, he said, the question is whether fewer recalls would occur if the life-sustaining devices were more frequently subject to the PMA approval process.

The FDA began officially regulating devices with the dual-pathway strategy in 1976. At that time, few devices were permanently implanted or intended to sustain life. Thus, the system was challenged as new devices changed more dramatically and became more complex, the researchers said.

In 2002, the Medical Device User Fee and Modernization Act further loosened regulations, allowing products made from different materials and using a different mechanism of action to go the route of 510(k) if they had a similar safety profile. It also expanded to include similarities to devices cleared through the 510(k) or PMA process.

But in September 2009, the agency asked the Institute of Medicine to review the approval process (which is expected to be completed in mid-2011), and released its own pair of reports in August 2010.

Yet last month, the FDA held off on implementing many of its proposed revisions after criticism from industry, and last week it announced a new "Innovation" pathway for outstanding medical devices.

For their study, Nissen and colleagues analyzed the FDA's high-risk list of device recalls from 2005 to 2009.

There were a total of 113 Class I recalls -- the most urgent -- during that time for devices the FDA determined had the potential to cause serious health problems or death.

Only 19% of the recalled devices were approved through the stricter PMA process, compared with 71% of those cleared via the 510(k) pathway.

About 7% of recalls involved devices that were exempt from any regulation -- while about 4% were counterfeit or categorized as "other" and didn't go through any of the three processes for approval, clearance, or registration, Nissen and colleagues noted.

Cardiovascular devices comprised the largest recall category, accounting for 31% of high-risk recalls. About two-thirds of these recalled devices were cleared via the 510(k) program; most of them were automated external defibrillators (AEDs).

Nissen said more than 20% of the almost one million AEDs in circulation were recalled by the FDA, and hundreds of people died due to AED malfunctions.

The next largest risk category, accounting for 24% of recalls, involved general hospital devices -- insulin pumps, intravenous infusion devices, and patient lifts. Of these, 74% had been approved via the 510(k) pathway, the researchers said.

They concluded that the findings suggest "reform of the regulatory process is needed to ensure the safety of medical devices."

Nissen and co-authors made several recommendations at the end of their report, including:

Life-saving and life-sustaining Class III devices should be subject to the PMA process.

FDA should expand its authority and inspect the manufacturing of 510(k) devices.

FDA must use controls for these devices, such as postmarket surveillance and performance standards.

In an accompanying editorial, Rita Redberg, MD, and Sanket Dhruva, MD, of the University of California San Francisco, agreed that there should be tougher standards for approval of more complicated devices.

"Although the FDA committed some time ago to require that high-risk devices be either evaluated through PMA or reclassified to a lower-risk class, neither has yet occurred," they wrote.

Redberg and Dhruva also called it "unfortunate" that the FDA had "backed down from several essential safeguards when it released its implementation plan in January 2011."

They concluded that the study "deepen[s] our concern about approved devices by showing that millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data."

This article was developed in collaboration with ABC News.

The study was supported by the National Research Center for Women & Families, which "does not accept contributions from medical device companies."

Nissen reported consulting for many pharmaceutical companies but "requires them to donate all honoraria or consulting fees directly to charity so that he neither receives income nor a tax deduction for his services."

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